This trial is active, not recruiting.

Condition melanoma
Treatments pembrolizumab, ipilimumab
Phase phase 3
Targets CTLA-4, PD-1
Sponsor Merck Sharp & Dohme Corp.
Start date August 2013
End date March 2015
Trial size 645 participants
Trial identifier NCT01866319, 2012-004907-10, 3475-006


This is a three-arm study to evaluate the safety and efficacy of two dosing schedules of pembrolizumab (MK-3475) compared to ipilimumab for the treatment of ipilimumab-naïve participants with unresectable or metastatic melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Participants receive pembrolizumab, 10 mg intravenously (IV), once every 2 weeks for up to 2 years
Participants receive pembrolizumab, 10 mg IV, once every 3 weeks for up to 2 years
(Active Comparator)
Participants receive ipilimumab, 3 mg/kg IV, once every 3 weeks for a total of 4 doses

Primary Outcomes

Progression-free Survival (PFS)
time frame: Up to 2 years
Overall survival (OS)
time frame: Up to 30 months

Secondary Outcomes

Overall response rate (ORR)
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Histologically-confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy (excluding uveal or ocular melanoma) - At least one measurable lesion - No prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (first line) or one prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (second line) - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Archived tissue sample or new biopsy sample - Female participants of childbearing potential and male participants must agree to use effective contraception from Visit 1 to 120 days after the last dose of study drug; male participants must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug Exclusion criteria: - Prior treatment with ipilimumab or other anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) agent or any anti-programmed cell death (PD-1 or PD-L2) agent - Chemotherapy, radioactive, or biological cancer therapy within four weeks prior to the first dose of study drug, or not recovered from adverse events caused by cancer therapeutics administered more than four weeks earlier - Currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug - Expected to require any other form of systemic or localized antineoplastic therapy while on study - On any systemic steroid therapy within one week before the planned date for first dose of randomized treatment or on any other form of immunosuppressive medication - History of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration, excluding adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other in situ cancers. - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases are eligible - Severe hypersensitivity reaction to treatment with another monoclonal antibody - Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents - Active infection requiring systemic therapy - Known history of Human Immunodeficiency Virus (HIV) - Known history of or positive for Hepatitis B or C - Known psychiatric or substance abuse disorder - Regular user (including recreational use) of illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) - Pregnant or breastfeeding, or expecting to conceive, or father children within the projected duration of the study

Additional Information

Official title A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of MK-3475 Compared to Ipilimumab in Patients With Advanced Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..